Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, supported the
recent presentation of a scientific poster at the European Society
of Cardiology (ESC) Congress in Munich, Germany. This
analysis indicated that patients with elevated triglycerides (TG)
were at a 37% higher rate of requiring a procedure for peripheral
arterial revascularization per unit time than patients with normal
TG levels. A conference call will be held Monday, August 27,
2018 to discuss this data and other data presented at ESC 2018 and
related insights with respect to Amarin’s potentially landmark
cardiovascular outcomes study of Vascepa®, REDUCE-IT™. Top-line
results from REDUCE-IT are anticipated before the end of September
2018.
The scientific poster #P739 is titled,
“Triglycerides 150 mg/dL and above are associated with an increased
risk of peripheral arterial revascularization in high-risk
statin-treated patients: A real-world analysis.” These data were
based on a retrospective analysis of de-identified medical records
from patient experiences within a leading national information and
technology-enabled health services business. De-identified
patient data is health information from a medical record that has
been stripped of all “direct identifiers”, that is, all information
that can be used to identify the patient from whose medical record
the health information was derived. The purpose of this
retrospective analysis of a large medical claims database was to
evaluate the real-world impact of elevated triglycerides on
occurrence of peripheral arterial revascularization in high-risk
statin-treated patients.
Patient data from the database were segmented
into groups of people with elevated TG levels (≥150 mg/dL,
n=22,795) and a control cohort with normal TG levels (<150
mg/dL, n=22,884). In a multivariate analysis, patients with
elevated TG levels were at a 37% higher rate of requiring a
procedure for peripheral arterial revascularization per unit time
than the control cohort. This analysis provides evidence to further
support that elevated triglycerides are associated with higher
rates of peripheral arterial revascularization.
This poster was authored by Peter P. Toth, MD,
PhD, CGH Medical Center, Sterling, IL; Sephy Philip, RPh, PharmD,
Amarin Pharma, Inc., Bedminster, NJ; Michael Hull, MS, Optum, Eden
Prairie, MN; Djibril Liassou, BA, Optum, Eden Prairie, MN; Amy
Anderson, MS, Optum, Eden Prairie, MN; and Craig Granowitz, MD,
PhD, Amarin Pharma, Inc., Bedminster, NJ.
“We are pleased to present this new information
that adds to our body of knowledge regarding the correlation of
elevated TG levels to increased risk of revascularization procedure
in patients with peripheral arterial disease (PAD).
Development of PAD often has a significant effect on patient
quality of life and drives healthcare utilization.
Unfortunately, PAD is growing as a common disease condition along
with changes in population demographics,” said Peter Toth, MD,
PhD.
PAD is associated with cardiovascular morbidity,
reduced quality of life, and increased health care burden.
1,2,3 More than 200 million people are affected with PAD
worldwide, including almost 40 million people in Europe.4 In the
United States, the prevalence of PAD is at least 6.8 million
individuals, with more than 13,000 deaths in 2015 and more than
100,000 hospital discharges in 2014.1 Interventions for peripheral
vascular disease are one of a number of prespecified data points
that are being collected in the Amarin REDUCE-IT cardiovascular
outcomes study.
Previously, Amarin presented a real-world data
analysis at the 2018 American College of Cardiology (ACC) 67th
Annual Scientific Session and Expo in Orlando, Florida. This
analysis reinforced that statin-treated patients at high
cardiovascular (CV) risk with controlled low density lipoprotein
cholesterol (LDL-C) and elevated triglyceride (TG) levels, TG
≥ 150 mg/dL, had worse CV outcomes and higher overall
healthcare costs than statin-treated patients with controlled LDL-C
and normal TG levels, TG < 150 mg/dL, and normal high density
lipoprotein cholesterol (HDL-C) > 40 mg/dL.
Patients with diabetes mellitus and/or
established atherosclerotic cardiovascular disease were followed
longitudinally for up to five years. Those patients with elevated
TG levels, defined as TG ≥ 150 mg/dL, as compared with the normal
TG group defined as TG < 150 mg/dL and HDL-C >40 mg/dL, were
at increased risk of adverse CV outcomes after multivariable
adjustment as follows:
- 26% increased risk for the composite initial major adverse CV
event (MACE) (95% confidence interval [CI] 1.19-1.34)
- The increase in composite MACE in the elevated TG group was
driven by a 32% (95% CI 1.20-1.45) increased risk of non-fatal
myocardial infarction and a 46% (95% CI 1.33-1.61) increased risk
of coronary revascularization
- 12% higher average total healthcare cost (95% CI
1.08-1.16)
- 13% higher rate of occurrence of initial inpatient hospital
stay (95% CI 1.10-1.17)
Conference Call and Webcast Information
Amarin will host a conference call
at 8:00 a.m. ET, August 27, 2018 to discuss this
presentation and other data presented at ESC 2018. The call
will be accessible through the investor relations section of the
company’s website at www.amarincorp.com. The call can also be heard
via telephone by dialing 877-407-8033. A replay of the call will be
made available for a period of two weeks following the conference
call. To hear a replay of the call, dial 877-481-4010 (inside the
United States) or 919-882-2331 (outside the United States). A
replay of the call will also be available through the company's
website shortly after the call. For both dial-in numbers please use
conference ID 37102.
About Amarin
Amarin Corporation plc is a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health. Amarin's
product development program leverages its extensive experience in
lipid science and the potential therapeutic benefits of
polyunsaturated fatty acids. Vascepa® (icosapent ethyl),
Amarin's first FDA-approved product, is a highly-pure, omega-3
fatty acid product available by prescription. For more
information about Vascepa visit www.vascepa.com. For more
information about Amarin visit www.amarincorp.com.
About REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any triglyceride
lowering therapy, as an add-on to statins in patients with high
cardiovascular risk who, despite stable statin therapy, have
elevated triglyceride levels (150-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study by the end of September 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl)
Capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient. Vascepa, known in scientific literature as
AMR101, has been designated a new chemical entity by the FDA.
Amarin has been issued multiple patents internationally based on
the unique clinical profile of Vascepa, including the drug’s
ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence > 2% and greater than placebo) was
arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no
reported adverse reaction > 3% and greater than placebo.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.1,
5
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease. 6, 7, 8, 9
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about the patient risk profiles
thought to be related to triglyceride levels as well as statements
concerning the REDUCE-IT cardiovascular outcomes study such as the
anticipated inclusion of certain patient populations, related
timing and announcements with respect to final outcomes and the
anticipated successful completion of the REDUCE-IT study. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Among the factors that
could cause actual results to differ materially from those
described or projected herein include uncertainties associated
generally with retrospective subset analyses, research on
biomarkers thought to be relevant in the treatment of
cardiovascular disease, research and development and clinical trial
risk generally, including the risk that study results in modest
sample sizes may not be predictive of future results in larger
studies, that studied parameters may not have clinically meaningful
effect and the risk that patents may not adequately protect Vascepa
against competition. A further list and description of these risks,
uncertainties and other risks associated with an investment in
Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent quarterly report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://investor.amarincorp.com/), including but not
limited to investor presentations and investor FAQs, Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References
1 Benjamin EJ, et al. American Heart
Association. 2018. Disease and Stroke Statistics-2018 Update.
Circulation. 2018;137:e67-e492.
2 Creager MA. Protecting Life and Limb in
Peripheral Artery Disease. Circulation. 2018;137:351-3.
3 Valdivielso P, et al. Peripheral
arterial disease, type 2 diabetes and postprandial lipidaemia: Is
there a link? World J Diabetes. 2014;5:577-85.
4 Fowkes FG, et al. Comparison of global
estimates of prevalence and risk factors for peripheral artery
disease in 2000 and 2010: a systematic review and analysis. Lancet.
2013;382:1329– 40.
5 American Heart Association. 2017. Cardiovascular disease: A
costly burden for America projections through 2035. At:
http://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf
Accessed August 23, 2018.
6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
7 Toth PP, Granowitz C, Hull M, et al. High triglycerides
increase cardiovascular events, medical costs, and resource
utilization in a real-world analysis of statin-treated patients
with high cardiovascular risk and well-controlled low-density
lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl
1):A15187.
8 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
9 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz Investor Relations and
Corporate Communications Amarin Corporation plc In U.S.: +1
(908) 719-1315 investor.relations@amarincorp.com Lee M. Stern Trout
Group In U.S.: +1 (646) 378-2992 lstern@troutgroup.com
Media Inquiries: Christy Maginn Burson-Marsteller In U.S.: +1
(646) 280-5210 Christy.Maginn@bm.com
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